Thursday, February 7, 2013

The deepening mystery over Seroquel Study 41 and Charles Schulz

The mystery over AstraZeneca’s notorious Study 41 has
deepened.

Study 41, if you recall, was one of the contested studies of
Seroquel that emerged in litigation against AstraZeneca.Internal emails and documents suggested that
the study was buried and the results spun, and that Charles Schulz appeared to be
involved.Here
is what I wrote about the study last month for the Mad
in America blog:

“Later, in a trial known as Study
41, AstraZeneca compared Seroquel XR – the extended release version of
Seroquel – to placebo in patients experiencing acute schizophrenia. The
University of Minnesota was one of the study sites, and Charles Schulz was the
site investigator. Remarkably, Study 41 showed Seroquel XR performing no better
than placebo for schizophrenia. In emails, AstraZeneca officials refer to
Study 41 as a “failed
study,” or “code red.” Advisors (such as Schulz) and employees were instructed not to discuss the
study. So what did AstraZeneca do? They buried it and tried it again, this
time in India, Bulgaria, Romania, the Philippines, Russia, Greece and South
Africa. That trial was called Study 132, and it turned out positively. So in
2007 AstraZeneca published that study in the Journal of Clinical
Psychiatry. The second author of that study was Charles Schulz, who
presented the data at the annual meeting of the American Psychiatric
Association and served as the academic point man in company press releases.”

Mike Howard filed a complaint with the university about
Schulz’s involvement in Study 41, pointing not only to the hiding of research
results but to the fact that the study randomized some acutely psychotic patients to placebos,
effectively depriving them of treatment for the duration of the study.The
responseto Howard came from Mark
Rotenberg, the General Counsel, who wrote, “Dr. Schulz did not participate in
Study 41, because no subjects were enrolled at the University.”

Rotenberg’s statement that Schulz was not involved appears
to be at odds with the published
study itself, which appeared in Psychopharmacology
Bulletin in 2008.In that journal article,
Schulz is listed as a Study 41 investigator.In fact, the published article has another surprise: Steven Olson is
also listed as an investigator for Study 41.Olson, of course, was the University of Minnesota principal investigator
for the CAFÉ
study in which Dan Markingson died.

This news raises a number of intriguing questions.Did Study 41 actually take place at the University of Minnesota?Was the
protocol approved by the IRB?Did Schulz
and Olson each sign a Form
1572 for the FDA?And why would
Rotenberg claim that Schulz did not participate in the study when the published
literature indicates that he did?

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Who we are

Fear and Loathing in Bioethics began life as blog for "Investigative Journalism and Bioethics," a class taught by Amy Snow Landa and Carl Elliott at the University of Minnesota. Although the class has ended, the blog has not. Most posts now are by Carl Elliott, a professor in the Center for Bioethics. However, they do not in any way represent the views or positions of the University of Minnesota.